BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2840046 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10562
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V109631, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# VA0295S, PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A STIMULATOR IMPLANTED ABOUT FOUR YEARS AGO THAT "REALLY DID NOT DO ANY GOOD" BECAUSE "SHE HAD TO CONTINUOUSLY USE [INCONTINENCE] PADS ALL DAY LONG". THE STIMULATOR HAD PREVIOUSLY BEEN ADJUSTED BY THE DOCTOR IN (B)(6) 2009, BUT IT WAS REPORTED THAT IT DID NOT "DO ANY GOOD". THE PATIENT REPORTED TROUBLE ADJUSTING THE STIMULATION IN (B)(6) 2009 AND STATED THERE WAS "NO STIMULATION INCREASE". THE PATIENT REPORTED THAT THE DOCTOR WAS THEN UNABLE TO ADJUST THE STIMULATOR IN 2012, STATING IT "DID NOT WORK". ABOUT ONE MONTH PRIOR TO THIS REPORT, THE PATIENT DECIDED TO HAVE REPLACEMENT SURGERY AND INQUIRED AS TO WHY THE FIRST STIMULATOR WAS NOT EFFECTIVE. NO INFORMATION REGARDING THE PATIENT'S OUTCOME WAS REPORTED EXCEPT THAT SHE WAS STILL WEARING A PAD ALL THE TIME, AND SHE WAS TRYING TO WAIT AND SEE HOW EFFECTIVE THE NEW STIMULATOR WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention